Catabasis shared today their Catabasis Connection newsletter, with updates on edasalonexent and information shared at the MDA Virtual Poster Session.
Boys with Duchenne demonstrate capsule swallowing abilities
In Catabasis’ experience with edasalonexent clinical trials, they saw that 4- to 7-year-old boys were able to learn how to swallow soft-gel capsules of two different sizes. Catabasis understands that learning to swallow capsules for the first time can be a challenge, and are happy that so many boys were successful at it.
In both the Phase 2 MoveDMD trial and the Phase 3 PolarisDMD trial, 97% of boys screened were able to swallow capsules and age did not impact the ability to take the larger 250 mg capsules. Catabasis also collected advice from families and physicians about teaching young boys to swallow capsules and included tips on social media and in their newsletter. They plan on sharing information with other investigators to provide educational resources for other clinical trials.
Phase 3 PolarisDMD trial enrolled expected patient population
In clinical trials, it is important to understand the group of patients enrolled. Catabasis compared the populations of the boys in the current Phase 3 PolarisDMD trial and the previous Phase 2 MoveDMD trial and found that baseline age, North Star Ambulatory Assessment (NSAA) score, and timed function test values (time to stand, 4-stair climb, and 10-meter walk/run) were similar with no significant differences in patient populations between the two trials.
Catabasis believes these findings support the design of the Phase 3 trial. They intend to continue sharing information about the enrolled population of boys in the future as Catabasis learns more.
Age-normative growth and normal adrenal function observed with edasalonexent
Dr. Erika Finanger, a Principal Investigator for our Phase 2 MoveDMD, Phase 3 PolarisDMD, and open-label extension GalaxyDMD trials, reviewed safety data of boys taking edasalonexent over 3 years. In Catabasis’ Phase 2 MoveDMD trial and open-label extension, edasalonexent treatment was well-tolerated and associated with favorable growth patterns and normal adrenal function, because it does not impact the glucocorticoid receptor.